Genentech-posted 7 months ago
$77,500 - $143,900/Yr
Full-time • Mid Level
Onsite • Hillsboro, OR
Chemical Manufacturing

This position is part of Genentech's Pharma Technical - individualized and cell therapy team based in Hillsboro, Oregon. In this critical role, you will be part of a dedicated cross-functional team working on production start-up activities including building GMP-compliant processes to manufacture, test and release products in a fully GMP-compliant facility, and the quality approach for this exciting and novel technology. In this role, you will be responsible for ensuring that both commercial and clinical (IMP) products meet specified requirements and are released in accordance with legal compliance and Roche quality standards. Your primary accountability will encompass reviewing and approving QA controlled documentation, including procedures and master batch records.

  • Ensure lot disposition and timely release of commercial and clinical products in compliance with internal standards and local/international laws
  • Create, revise, and review quality documents; provide oversight for operational procedures to maintain GMP compliance
  • Lead and support cross-functional projects and Quality initiatives; resolve Quality risks through interdepartmental collaboration
  • Assess and resolve deviations promptly, partnering with functional areas to investigate and address product quality impacts; manage CAPA processes effectively
  • Meet budgetary goals for QA Operations and promote a positive safety culture aligned with Safety, Health and Environment requirements
  • Provide Quality Assurance oversight of end-to-end production operations, including Chain of Custody and Chain of Identity
  • Participate in internal and external audits as a Subject Matter Expert, ensuring readiness for inspections and defending lot disposition practices and GMP compliance
  • Collaborate with Manufacturing, Site functions, PTD, Affiliate Quality Assurance Management, Regulatory (PTR), Global Quality System and Management, External Quality, Supplier Quality, suppliers, and CMOs to ensure cohesive quality standards and compliance across all operations
  • Bachelor's Degree (preferably in Pharmacy, Pharmaceutical, bioengineering, Chemistry or other relevant discipline)
  • At least 3 years of pharmaceutical or related life science industry experience for QA Specialist III
  • At least 6 years of work experience in the pharmaceutical or related life science industry for Senior QA Specialist
  • At least 3 years of experience in Quality Assurance, Quality Control, Manufacturing for QA Specialist III
  • At least 8 years of experience in Quality Assurance, Quality Control, Manufacturing for Senior QA Specialist
  • Knowledge of Quality Assurance principles, practices, and standards for the biopharmaceutical industry
  • Understanding of GMP relevant to the pharmaceutical industry and knowledge of local and international GMP regulations; knowledge of regulations related to ATMP is desirable
  • Strong verbal and technical written communication skills, excellent interpersonal skills, and negotiation skills
  • Effective problem-solver
  • Familiarity with computer systems and aptitude to quickly become familiar with new software (e.g., EDMS, LIMS, SAP)
  • Relocation benefits are approved for this position
  • Discretionary annual bonus may be available based on individual and Company performance
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